We are seeking an experienced, innovative and highly motivated professional to contribute towards the discovery and development of novel biological cattle vaccines. As such you will be designing and executing bovine livestock biological pilot and pivotal, clinical and non-clinical studies in compliance with regulatory requirements. Provide expertise and support in the areas of study conduct to livestock biologicals research-phase projects.
- Is responsible for overall conduct of clinical studies in support of Veterinary Medicine Research & Development (VMRD) cattle biologicals research and development projects, i.e. budgeting, investigator/site selection, protocol development/writing, monitoring, report writing.
- Collaborate with Regulatory Affairs to gain concurrence for protocol approval and report/data submission with the Center for Veterinary Medicine (CVB). May also be involved in studies to support approvals in the EU or the rest of the world.
- Collaborate with Clinical team to update the full project team with regards to study status, activities, timelines, outcomes, etc. Identify when resource, time, and/or budget constraints occur and work with the Project Manager and Project Team Leader to identify solutions.
- Ensure that studies are conducted in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements and guidelines (e.g., Good Clinical Practice and Good Laboratory Practice).
EDUCATION AND EXPERIENCE
DVM with 3 years cumulative experience in either U.S. livestock (bovine/swine) production and/or private livestock practice experience and/or livestock biological/biopharmaceutical product development experience.
DVM with 3 years cumulative experience in bovine livestock production-related discipline and with livestock biological product development experience and a PhD/MSc in microbiology and /or parasitology.